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Abstract Details

Activity Number: 619
Type: Contributed
Date/Time: Thursday, August 2, 2012 : 8:30 AM to 10:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #306261
Title: Use of Order-Restricted Simultaneous Inferences in Clinical Dose Study Data Analysis
Author(s): Gang Jia*+
Companies: Merck Research Laboratories
Address: , , ,
Keywords: dose study ; Simultaneous Inferences ; Phase II ; dose response

Clinical dose study is an important part of drug development. A Phase II clinical dose trial usually studies the drug efficacy at multiple dose levels and is usually conducted on a number of fixed dose levels. In many cases, drug response can be assumed to be monotone increasing or decreasing on dosage. Parametric dose response form is usually not appropriate besides monotone assumption due to: 1. there are not enough dose levels for reliable estimate of parametric function, 2. estimate of drug effect at extreme dose range are least accurate, and 3. there is usually no prior information on dose response shape. The order-restricted simultaneous inferences help to provide information on potential treatment efficacy and effect size, which are used to plan and design Phase III study.

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